PROJECT SUMMARY/ABSTRACT This R34 application, led by an Early Stage Investigator, aims to understand and address the multiple ways in which gender-based violence (GBV) impacts the effective use of oral pre-exposure prophylaxis (PrEP) by adolescent girls and young women (AGYW) ages 15-24 in Kenya. AGYW account for 25% of all HIV new infections in sub-Saharan Africa. Although PrEP has the potential to reduce HIV risk in this population, adherence has been low among young African women in previous studies, limiting its protective benefit. Many current studies aim to increase PrEP uptake and adherence among AGYW, but none, to our knowledge, incorporate targeted PrEP interventions for GBV survivors. In Kenya, the lifetime prevalence of physical or sexual GBV among AGYW is over 40%, and GBV is associated with higher HIV incidence and lower adherence to PrEP. There is an urgent need for effective interventions to address GBV- specific barriers to PrEP uptake and adherence, to reduce HIV risk in this vulnerable group. We propose to conduct formative research to better understand individual-, partner-, community-, and clinic-level barriers to PrEP uptake and adherence in AGYW GBV survivors. Based on this formative work, we will develop and pilot an intervention to address these barriers. The research will be nested within the ongoing DREAMS HIV prevention activities for AGYW, including PrEP delivery, implemented by Impact Research and Development Organization (IRDO) in Siaya County, western Kenya. The specific aims are 1) to characterize patterns of PrEP uptake and adherence among young GBV survivors, and to understand their unique barriers and facilitators to PrEP use, by means of mixed-methods formative research; 2) to develop and pre-test an intervention that addresses multi-level GBV-related barriers to PrEP use among AGYW; and 3) to implement and assess the feasibility, safety, and preliminary effects of the resulting intervention through a pilot cluster randomized-controlled trial (cRCT) with 100 AGYW GBV survivors at four PrEP delivery sites. Key intervention components can be integrated and sustained within adherence support activities for all AGYW, and include GBV screening; video vignettes to role model successful PrEP use; adherence support clubs; counseling on safety planning and disclosure; and provider training and support. Primary outcomes of the pilot cRCT will include feasibility and safety. We will also determine whether the intervention shows promise in increasing PrEP uptake, adherence, and persistence at 6 months. We will conduct participant in-depth interviews and provider focus groups to explore acceptability and effects on PrEP decision-making. The proposed work is innovative because it builds on the existing DREAMS Initiative and engages youth in intervention design. The focus on GBV survivors is novel and fills a critical gap in our efforts to end the HIV epidemic. If successful, the findings will provide robust preliminary data for an R01 proposal to test the efficacy of this intervention on PrEP uptake, persistence, and biologic markers of adherence in a fully powered multisite RCT.